印度医疗器材登记法规问题集
Email：bom4ww@evershinecpa.com
或
印度永辉BPO有限公司
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The Engaging Manager Punit Negi, Indian citizenship
或
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联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
HLF-TW-10
请问印度对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of medical devices in India? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在印度，医疗器材由中央药品标准控制组织 (CDSCO)辖下的印度药品总局 (DCGI) 监管，对于医疗器材的进口、生产场所、产品皆需要在DCGI进行註册。
医疗器材是指任何设备，包括仪器、装置、器具、植入物、材料或其他物品，包括软体、硬体，可以是单独或组合使用于人体或动物，因为无法通过药理学、免疫学或代谢手段达到预期目的，可以通过设备辅助其预期功能，用于以下一项或多项目的：
1. 任何疾病或病症的诊断、预防、监测、治疗或缓解。
2. 任何伤害或残疾的诊断、监测、治疗、缓解或援助。
3. 解剖或生理过程的调查、替换或修改或支持。
4. 支持或维持生命。
5. 医疗器材消毒。
6. 控制受孕。
医疗器材依据风险程度分成四类
1. A等级(低风险)：未公告强制列检的医材品项(例如：血压计、绷带、纱布等)
2. B等级(中风险)：现行分类标准公告B等级品项(例如：球囊导管、支气管导管等)
3. C等级(中高风险)：现行分类标准公告C等级品项(例如：呼吸机、生化贴片、测试试剂/试剂盒等)
4. D等级(高风险)：现行分类标准公告D等级品项(例如：人工心脏瓣膜、椎间盘假体等)
在印度境内製造A等级(低风险)、B等级(中风险)医疗器材以供贩售、流通使用或租赁之医材製造商，依法应向省立药品管制局申请製造许可证；製造C等级(中高风险)、D等级(高风险)医疗器材以供贩售、流通使用或租赁之医材製造商，依法应向CDSCO申请製造许可证。
In India, medical devices are regulated by the Directorate General of Drugs of India (DCGI) under the Central Drug Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, and the import, production sites and products of medical devices need to be registered with DCGI.
Medical device means any device, including instruments, devices, appliances, implants, materials, or other items, including soft, hard The means achieve the intended purpose, and the intended function can be assisted by the equipment for one or more of the following:
1. Diagnosis, prevention, monitoring, treatment or mitigation of any disease or condition.
2. Diagnosis, monitoring, treatment, relief or assistance of any injury or disability.
3. The investigation, replacement or modification or support of an anatomical or physiological process.
4. Supporting or sustaining life.
5. Medical device disinfection.
6. Controlling conception.
Medical devices are classified into four categories according to the degree of risk
1. Class A (low risk): medical materials items that have not been announced for mandatory inspection (such as sphygmomanometers, bandages, gauze, etc.)
2. Class B (medium risk): The current classification standard announces B grade items (for example: balloon catheter, bronchial catheter, etc.)
3. Class C(medium-high risk): C-level items announced in the current classification standard (for example: ventilators, biochemical patches, test reagents/kits, etc.)
4. Class D(high risk): the current classification standard announces D grade items (for example: artificial heart valve, intervertebral disc prosthesis, etc.)
Manufacturers of medical materials that manufacture Class A (low risk) and Class B (medium risk) medical devices for sale, circulation or lease in India shall apply for a manufacturing license to the Provincial Drug Control Bureau according to law; manufacturing Class C Manufacturers of medical materials (medium-high risk) and D-level (high-risk) medical device for sale, circulation or lease should apply to CDSCO for a manufacturing license according to law.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Home/
HLF-TW-20
外国公司要到印度销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell medical devices in India, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无须申请营业许可证
No business license is required.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-25
假如需要办理，请问印度有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
无须申请营业许可证
HLF-TW-30
外国公司要到印度销售医疗器材，可以指派印度公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell medical devices in India, can it assign an India company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。可指定印度当地公司成为代理人并註册医疗器材进口许可证。
当发生不良事件，主管机关有权力要求进口商立即启动召回，以防用户或患者的健康构成风险。进口商有责任说明其撤回的原因、发送通知，并且需要提交定期安全性更新报告并建立警戒系统。
Yes. The medical device import license must be registered in the name of a local company in India.
When an adverse event occurs, the competent authority has the power to require the importer to initiate a recall immediately, in case the health of the user or patient poses a risk. Importers are responsible for explaining the reasons for their withdrawal, sending notices, and are required to submit regular security updates and establish a vigilance system.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-35
HLF-TW-40
外国公司销售到印度医疗器材本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing medical devices sold to India?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，须以印度当地公司名义註册医疗器材进口许可证。
流程
1. 至CDSCO设立网页註册：
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. 申请者需上传以下文件进行註册：
．身份证明详情
．声明
．公司地址详情（公司註册证书）
．製造许可证和批发许可证的副本（如果没有，则上传等同的证明）
3. 完成验证后登录，缴交以下註册文件，文件须以英语提供。
註册文件
1. 当地公司/企业名称、地址
2. 医疗器材内容
．通用名称
．型号
．用途
．医疗器材分类
．结构材料
．尺寸
．有效期
．无菌或非无菌
．品牌
3. 由国家认证机构认证委员会或国际认证论坛认可此类医疗器材符合 ISO 13485 标准的证明，进口商註册医疗器材后，必须严格遵守其成文的质量管理体系。
如果CDSCO认定境外製造厂QMS之符合性存在疑虑时，可以要求实施评估、产品测试或检验程序，此时，如果CDSCO要求必须透过海外查厂的方式确认境外製造厂QMS之符合性，依法应由进口商负担海外查厂之费用。
4. 製造商承诺书，声明申请人提供的信息真实、可靠。
5. 原产国的自由销售证明。
6. 进口商提出的产品註册由DCGI审核，处理申请的规定时间自申请之日起最多 9 个月。
7. 所有医疗器材（A、B、C、D 类）的风险分类由 DCGI 认定。註册C、D类器材需要证明其安全性。
CDSCO审核安全性与有效性之文件要求，会依照产品原产国是否来自先进国家而有差异。
产品原产国若属先进国家，依法提出前述自由销售许可或原产国实施临床测试数据资料作为证明文件即可，但若进口医疗器材之原产国为先进国家以外之其他国家，则必须在印度实施临床测试，以确认产品之安全性与有效性。
8. 放宽条件
．2020 年 4 月 1 日至 2021 年 9 月 30 日製造、进口、分销或销售新申报的医疗器材无需註册或许可。
．2021 年 10 月 1 日至 2022 年 9 月 30 日进口或製造的医疗器材需要註册，但不需要许可证。
．2022 年 10 月 1 日至 2023 年 9 月 30 日製造、进口、分销或销售 A 类或 B 类医疗器材需要许可证，但製造、进口、分销或销售 C 类或 D 类医疗器材不需要许可证。
．2023 年 10 月 1 日之后製造、进口、分销或销售 C 类和 D 类医疗器材也需要许可证。
9. 2017进口许可证除非提前暂停或取消，否则将永久有效。
标籤
应以不褪色的墨水将下列细节印在标籤上、医疗器材的货架包装上或医疗器材的每个外壳上：
1. 医疗器材的名称
2. 用户识别设备及其使用所需的详细信息
3. 製造商名称和製造场所的地址
4. 正确说明重量、尺寸、体积、单位数量（视情况而定）和包装中包含的淨数量(以公製表示)。
5. 製造和到期的月份和年份（或者标籤应标明产品的保质期）： 如果是无菌器材，灭菌日期可以作为器材的製造日期。如果器材由不锈钢或钛等稳定材料製成，并且以非无菌方式提供，则可能不需要有效期。
6. 提供含有药用或生物物质的指示(如果适用)。
7. 带有“批号”字样的独特批号。
8. 指明适用于该器材的任何特殊储存或处理条件(如果适用)。
9. 如果器材作为无菌产品提供，则说明其无菌状态和灭菌方法。
10. 给予警告或预防措施以引起医疗器材用户的注意。
11. 如果设备是一次性使用的需标记。
12. 如果医疗器材打算作为免费样品分发给医疗专业人员，则在器材标籤上套印“医师样品—不得出售”字样。
13. 标示製造许可证号或“Mfg. Lic. No.” 或 “M. L”。
14. 进口器材可以用贴纸的方式提供进口许可证号、进口商名称与地址、实际製造场所的地址、製造日期(前提是标籤有印度标准局或国际标准化组织 (ISO) 认可的符号来代替文本，并且设备安全不会因用户缺乏理解而受到影响。)
15. 对于无法清晰列出信息的小型医疗器材，应包括产品标识和安全所需的信息。
16. 设备标识符号：是指全球贸易项目编号。
17. 生产标识符号：是指序列号、批号。
18. 标籤应以英文提供。
The medical device import license must be registered in the name of a local company in India.
Process
1. Set up web registration at CDSCO:
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. Applicants are required to upload the following documents for registration:
．ID Details
．Statement
．Company Address Details (Company Registration Certificate)
．Copies of Manufacturing License and Wholesale License (upload equivalent if not available)
3. After completing the verification, log in, and submit the following registration documents. The documents must be provided in English.
Required Documents for Registration
1. Local Company/Business Name, Address
2. Contents of Medical Devices
．Generic name
．Model
．Purpose
．Classification of medical device
．Structural materials
．Size
．Validity period
．Sterile or Non-sterile
．Brand
3. Certification by the National Accreditation Body Accreditation Committee or International Accreditation Forum that such medical devices conform to the ISO 13485 standard, and importers must strictly abide by their documented quality management system after registering the medical device. If CDSCO determines that there are doubts about the compliance of the QMS of the overseas manufacturer, it may request the implementation of assessment, product testing or inspection procedures. The importer shall bear the cost of overseas factory inspection.
4. A letter of commitment from the manufacturer, stating that the information provided by the applicant is true and reliable.
5. Proof of free sale in the country of origin.
6. The product registration proposed by the importer is reviewed by DCGI, and the prescribed time for processing the application is a maximum of 9 months from the date of application.
7. Risk classification for all medical devices (Class A, B, C, D) is determined by DCGI. Registration of Class C and D equipment requires proof of its safety. The documentation requirements for CDSCO to review safety and efficacy vary depending on whether the country of origin of the product is from an advanced country. If the country of origin of the product is an advanced country, it is sufficient to submit the aforementioned free sales license or the implementation of clinical test data in the country of origin as a certification document. However, if the country of origin of imported medical device is a country other than an advanced country, it must be India conducts clinical tests to confirm the safety and efficacy of products.
8. Relax conditions
．No registration or license is required to manufacture, import, distribute or sell newly declared medical devices from April 1, 2020 to September 30, 2021.
．Medical devices imported or manufactured between October 1, 2021 and September 30, 2022 require registration, but no license.
．A license is required to manufacture, import, distribute, or sell Class A or B medical devices from October 1, 2022 to September 30, 2023, but no license is required to manufacture, import, distribute or sell Class C or D medical devices .
．A license is also required to manufacture, import, distribute, or sell Class C and D medical devices after October 1, 2023.
9. The 2017 import license will be valid in perpetuity unless suspended or cancelled in advance.
Label
The following details shall be printed in non-fading ink on the label, on the shelf packaging of the medical device, or on each housing of the medical device:
1. The name of the medical device
2. User identification of the device and details required for its use
3. Manufacturer’s name and address of manufacturing site
4. Correctly state the weight, dimensions, volume, unit quantity (as applicable) and net quantity (in metric) contained in the package.
5. Month and Year of Manufacture and Expiration (or the label should indicate the expiration date of the product): In the case of sterile equipment, the sterilization date may be used as the date of manufacture of the equipment. If the device is made of a stable material such as stainless steel or titanium, and is supplied in a non-sterile manner, an expiration date may not be required.
6. Provide indication of containing medicinal or biological substances (if applicable).
7. Unique lot number with the word “Lot”.
8. Indicate any special storage or handling conditions applicable to the equipment, if applicable.
9. If the device is supplied as a sterile product, state its sterile condition and method of sterilization.
10. Give warnings or precautions to the attention of the user of the medical device.
11. Mark the device if it is for single use.
12. If the medical device is intended to be distributed as a free sample to medical professionals, overprint the words “Physician Sample – Not For Sale” on the device label.
13. Indicate the manufacturing license number or “Mfg. Lic. No.” or “M. L”.
14. Imported equipment may provide the import license number, importer’s name and address, address of the actual manufacturing site, date of manufacture in the form of a sticker (provided that the label has a symbol approved by the Bureau of Indian Standards or the International Organization for Standardization (ISO) in place of the text) , and device security is not compromised by lack of user understanding.)
15. For small medical devices whose information cannot be clearly listed, the information required for product identification and safety should be included.
16. DT Symbol: means the Global Trade Item number.
17. Production identification number: refers to the serial number, batch number.
18. Labels shall be available in English.
【参考连结】
HLF-TW-45
HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？
需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
须以印度当地公司名义註册医疗器材进口许可证。
流程
1. 至CDSCO设立网页註册：
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. 申请者需上传以下文件进行註册：
．身份证明详情
．声明
．公司地址详情（公司註册证书）
．製造许可证和批发许可证的副本（如果没有，则上传等同的证明）
3. 完成验证后登录，缴交以下註册文件，文件须以英语提供。
医疗器材註册所需文件
1. 当地公司/企业名称、地址
2. 医疗器材内容
．通用名称
．型号
．用途
．医疗器材分类
．结构材料
．尺寸
．有效期
．无菌或非无菌
．品牌
3. 由国家认证机构认证委员会或国际认证论坛认可此类医疗器材符合 ISO 13485 标准的证明，进口商註册医疗器材后，必须严格遵守其成文的质量管理体系。如果CDSCO认定境外製造厂QMS之符合性存在疑虑时，可以要求实施评估、产品测试或检验程序，此时，如果CDSCO要求必须透过海外查厂的方式确认境外製造厂QMS之符合性，依法应由进口商负担海外查厂之费用。
4. 製造商承诺书，声明申请人提供的信息真实、可靠。
5. 原产国的自由销售证明。
6. 进口商提出的产品註册由DCGI审核，处理申请的规定时间自申请之日起最多 9 个月。
7. 所有医疗器材（A、B、C、D 类）的风险分类由 DCGI 认定。註册C、D类器材需要证明其安全性。CDSCO审核安全性与有效性之文件要求，会依照产品原产国是否来自先进国家而有差异。产品原产国若属先进国家，依法提出前述自由销售许可或原产国实施临床测试数据资料作为证明文件即可，但若进口医疗器材之原产国为先进国家以外之其他国家，则必须在印度实施临床测试，以确认产品之安全性与有效性。
8. 放宽条件
．2020 年 4 月 1 日至 2021 年 9 月 30 日製造、进口、分销或销售新申报的医疗器材无需註册或许可。
．2021 年 10 月 1 日至 2022 年 9 月 30 日进口或製造的医疗器材需要註册，但不需要许可证。
．2022 年 10 月 1 日至 2023 年 9 月 30 日製造、进口、分销或销售 A 类或 B 类医疗器材需要许可证，但製造、进口、分销或销售 C 类或 D 类医疗器材不需要许可证。
．2023 年 10 月 1 日之后製造、进口、分销或销售 C 类和 D 类医疗器材也需要许可证。
9. 2017进口许可证除非提前暂停或取消，否则将永久有效。
标籤
应以不褪色的墨水将下列细节印在标籤上、医疗器材的货架包装上或医疗器材的每个外壳上：
1. 医疗器材的名称
2. 用户识别设备及其使用所需的详细信息
3. 製造商名称和製造场所的地址
4. 正确说明重量、尺寸、体积、单位数量（视情况而定）和包装中包含的淨数量(以公製表示)。
5. 製造和到期的月份和年份（或者标籤应标明产品的保质期）： 如果是无菌器材，灭菌日期可以作为器材的製造日期。如果器材由不锈钢或钛等稳定材料製成，并且以非无菌方式提供，则可能不需要有效期。
6. 提供含有药用或生物物质的指示(如果适用)。
7. 带有“批号”字样的独特批号。
8. 指明适用于该器材的任何特殊储存或处理条件(如果适用)。
9. 如果器材作为无菌产品提供，则说明其无菌状态和灭菌方法。
10. 给予警告或预防措施以引起医疗器材用户的注意。
11. 如果设备是一次性使用的需标记。
12. 如果医疗器材打算作为免费样品分发给医疗专业人员，则在器材标籤上套印“医师样品—不得出售”字样。
13. 标示製造许可证号或“Mfg. Lic. No.” 或 “M. L”。
14. 进口器材可以用贴纸的方式提供进口许可证号、进口商名称与地址、实际製造场所的地址、製造日期(前提是标籤有印度标准局或国际标准化组织 (ISO) 认可的符号来代替文本，并且设备安全不会因用户缺乏理解而受到影响。)
15. 对于无法清晰列出信息的小型医疗器材，应包括产品标识和安全所需的信息。
16. 设备标识符号：是指全球贸易项目编号。
17. 生产标识符号：是指序列号、批号。
18. 标籤应以英文提供。
The medical device import license must be registered in the name of a local company in India.
Process
1. Set up web registration at CDSCO:
https://cdscomdonline.gov.in/NewMedDev/Homepage
2. Applicants are required to upload the following documents for registration:
．ID Details
．Statement
．Company Address Details (Company Registration Certificate)
．Copies of Manufacturing License and Wholesale License (upload equivalent if not available)
3. After completing the verification, log in, and submit the following registration documents. The documents must be provided in English.
Required Documents for Medical Device Registration
1. Local Company/Business Name, Address
2. Contents of Medical Devices
．Generic name
．Model
．Purpose
．Classification of medical device
．Structural materials
．Size
．Validity period
．Sterile or Non-sterile
．Brand
3. Certification by the National Accreditation Body Accreditation Committee or International Accreditation Forum that such medical devices conform to the ISO 13485 standard, and importers must strictly abide by their documented quality management system after registering the medical device. If CDSCO determines that there are doubts about the compliance of the QMS of the overseas manufacturer, it may request the implementation of assessment, product testing or inspection procedures. The importer shall bear the cost of overseas factory inspection.
4. A letter of commitment from the manufacturer, stating that the information provided by the applicant is true and reliable.
5. Proof of free sale in the country of origin.
6. The product registration proposed by the importer is reviewed by DCGI, and the prescribed time for processing the application is a maximum of 9 months from the date of application.
7. Risk classification for all medical devices (Class A, B, C, D) is determined by DCGI. Registration of Class C and D equipment requires proof of its safety. The documentation requirements for CDSCO to review safety and efficacy vary depending on whether the country of origin of the product is from an advanced country. If the country of origin of the product is an advanced country, it is sufficient to submit the aforementioned free sales license or the implementation of clinical test data in the country of origin as a certification document. However, if the country of origin of imported medical device is a country other than an advanced country, it must be India conducts clinical tests to confirm the safety and efficacy of products.
8. Relax conditions
．No registration or license is required to manufacture, import, distribute or sell newly declared medical devices from April 1, 2020 to September 30, 2021.
．Medical devices imported or manufactured between October 1, 2021 and September 30, 2022 require registration, but no license.
．A license is required to manufacture, import, distribute, or sell Class A or B medical devices from October 1, 2022 to September 30, 2023, but no license is required to manufacture, import, distribute or sell Class C or D medical devices .
．A license is also required to manufacture, import, distribute, or sell Class C and D medical devices after October 1, 2023.
9. The 2017 import license will be valid in perpetuity unless suspended or cancelled in advance.
Label
The following details shall be printed in non-fading ink on the label, on the shelf packaging of the medical device, or on each housing of the medical device:
1. The name of the medical device
2. User identification of the device and details required for its use
3. Manufacturer’s name and address of manufacturing site
4. Correctly state the weight, dimensions, volume, unit quantity (as applicable) and net quantity (in metric) contained in the package.
5. Month and Year of Manufacture and Expiration (or the label should indicate the expiration date of the product): In the case of sterile equipment, the sterilization date may be used as the date of manufacture of the equipment. If the device is made of a stable material such as stainless steel or titanium, and is supplied in a non-sterile manner, an expiration date may not be required.
6. Provide indication of containing medicinal or biological substances (if applicable).
7. Unique lot number with the word “Lot”.
8. Indicate any special storage or handling conditions applicable to the equipment, if applicable.
9. If the device is supplied as a sterile product, state its sterile condition and method of sterilization.
10. Give warnings or precautions to the attention of the user of the medical device.
11. Mark the device if it is for single use.
12. If the medical device is intended to be distributed as a free sample to medical professionals, overprint the words “Physician Sample – Not For Sale” on the device label.
13. Indicate the manufacturing license number or “Mfg. Lic. No.” or “M. L”.
14. Imported equipment may provide the import license number, importer’s name and address, address of the actual manufacturing site, date of manufacture in the form of a sticker (provided that the label has a symbol approved by the Bureau of Indian Standards or the International Organization for Standardization (ISO) in place of the text) , and device security is not compromised by lack of user understanding.)
15. For small medical devices whose information cannot be clearly listed, the information required for product identification and safety should be included.
16. DT Symbol: means the Global Trade Item number.
17. Production identification number: refers to the serial number, batch number.
18. Labels shall be available in English.
【参考连结】
HLF-TW-55
HLF-TW-60
经过核准登记的医疗器材，进口到印度要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved medical devices into India? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
需取得进出口代码 (IEC)及进口商许可证才可以进口医疗器材至印度。
无销售许可证，但经销商必须保存所有销售纪录。
进出口代码 (IEC)
IEC 编号是对外贸易总干事颁发给印度公司的10位数代码。每个从事进出口业务的个人或实体都必须获得 IEC。
它具有终身有效期，大约需要 15 天才能签发。
1.网页註册：https://www.dgft.gov.in/CP/
．获得 IEC 的公司的性质可以是以下任何一种：独资企业、合伙企业、有限责任合伙企业、有限公司、信託、HU”。
引入 GST 后，IEC 编号与公司的 PAN 相同。IEC 将由 DGFT 单独发布。
2.签署声明。
3.支付IEC费用。
4.签发IEC代码。
进口流程
1.于印度海关电子网关 (ICEGATE)註册会员
印度海关电子网关 (ICEGATE) 是印度海关中央间接税和海关委员会 (CBIC) 的国家门户，以电子方式向贸易、货运承运人和其他贸易伙伴提供电子申报服务。网页：https://www.icegate.gov.in/index.html
．申请人
．公司名称
．地址
．城市
．密码
．电话、传真号码、电子信箱
．类别：进口商/出口商等
．清关位置
．内容、发货地、收货地
．货物的详情、货物登记
．商业发票
．合约
．提单
．QMS证明
．标籤样本(需提供翻译文件)
．收方公司IEC Code
．收货人个人证件影本(PAN：永久帐户号/TAN：收税及减税帐号/身份证/护照)
．通过电子现金分类账支付和电子税收信用分类。
2.清关需要文件
．商业发票
．装箱单
．分析证书
．原产地证书
．空运提单/货运提单
．保险凭证
．货运证明
．目录/技术说明
．进口许可证
．追踪货件
．原产国自由销售证明
．质量管理体系证书/完整质量保证证书/生产质量保证证书的公证副本
．公告机构/国家监管机构或其他主管机构在过去三年内进行的最新检查或审计报告的副本(如果具备)
3.必须在2-3天内清关。
4.完成入境单评估后、文件通过审查，货物将进行电子检查，经由海关人员批准后取得通关提货。
An Import and Export Code (IEC) and an importer’s license are required to import medical devices into India.No sales license, but distributors must keep all sales records.
Import/Export Code (IEC)
The IEC number is a 10-digit code issued by the Director General of External Trade to Indian companies. Every person or entity engaged in importing or exporting business must obtain IEC. It is valid for life and takes approximately 15 days to issue.
1. Web registration: https://www.dgft.gov.in/CP/
．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.
2. Sign the statement.
3. Pay the IEC fee.
4. Issue the IEC code.
Import procedure
1. Register as a member in India Customs Electronic Gateway (ICEGATE)
The Indian Customs Electronic Gateway (ICEGATE) is the national portal of the Central Indirect Tax and Customs Board (CBIC) of Customs of India, providing electronic declaration services to trades, freight carriers and other trading partners electronically. URL: https://www.icegate.gov.in/index.html
．Applicant
．Company Name
．Address
．City
．Password
．Telephone, fax number, e-mail
．Category: Importer/Exporter etc.
．Customs clearance location
．Contents, place of origin, place of receipt
．Details of cargo, cargo registration
．Commercial invoice
．Contract
．B/L
．QMS certificate
．Label sample (translation file required)
．Receiving company IEC Code
．Photocopy of the consignee’s personal ID (PAN: Permanent Account Number/TAN: Tax and Tax Deduction Account Number/ID Card/Passport)
．Payment via electronic cash ledger and electronic tax credit sorting.
2. Customs clearance requires documents
．Commercial invoice
．Packing List
．Certificate of Analysis
．Certificate of Origin
．Air Waybill / Freight Bill of Lading
．Certificate of Insurance
．Shipping certificate
．Catalog/Technical Notes
．Import permit
．Track your shipment
．Certificate of Free Sale in the Country of Origin
．Notarized copy of quality management system certificate/full quality assurance certificate/production quality assurance certificate
．A copy of the latest inspection or audit report conducted by the Notified Body/National Regulatory Authority or other competent authority within the past three years (if available)
3. Customs clearance must be done within 2-3 days.
4. After completing the assessment of the entry form and the documents passing the review, the goods will be electronically inspected, and the goods will be cleared and picked up after being approved by the customs personnel.
【参考连结】
https://www.cbic.gov.in/htdocs-cbec/customs
HLF-TW-70
印度医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
质量管理体系规范(QMS)
医疗器材的製造应符合要求，建立、记录、实施和维护质量管理并保持其有效性，文件应包括：
1. 质量方针和质量目标的书面陈述。
2. 质量手册。
．质量管理体系的范围，包括任何排除或不适用或两者兼有的细节和理由。
．为质量管理体系建立的文件化程序，或对其的引用。
．对质量管理体系过程之间相互作用的描述。 包含设施、人员和其他细节的具体信息。
3. 文件化程序。
4. 製造商为确保其过程的有效规划、操作和控制所需的文件。
5. 程序、活动或特殊安排的记录。
6. 文件控制应按照记录控制中给出的要求进行控制。文件应由适当的授权人员批准、签署并註明日期。
应建立形成文件的程序来定义所需的控制
．在发布前充分审查和批准文件
．必要时审查和更新文件并重新批准文件
．确保识别文件的变更和目前的修订状态
．确保申请文件所使用的版本是合适的
．确保文件保持清晰和易于识别
．确保识别来自外部的文件并控制其分发
．防止对过时文件的意外使用
7. 记录控制：应在医疗器材有效期届满后至少保留一年的记录。
8. 管理责任：製造商的高层管理人员应提供其致力于开发和实施质量管理系统的承诺，并通过以下方式维持其有效性。
．与员工沟通满足客户以及法定和监管要求的重要性
．制定质量政策
．确保建立优质目标
．进行管理评论
．确保资源的可用性
9. 质量方针：製造商的最高管理者应确保质量方针
．适合製造设施的目的
．包括遵守要求和保持质量管理体係有效性的承诺
． 提供建立和审查质量目标的框架
．在製造商组织内沟通
．审查持续适用性
10. 质量目标：製造商的高层管理人员应确保在製造组织内的相关功能和级别建立质量目标，包括满足产品要求所需的目标。质量目标应可衡量，并与质量政策一致。
11. 资源提供：製造组织应确定并提供所需的资源
．实施质量管理并保持其有效性
．符合法规和满足客户要求
12. 人力资源：从事影响产品质量工作的人员应受适当的教育、培训、技能。僱用的人员数量应充足，并与工作量成正比。
所有人员上岗前均应进行体检，包括眼科检查，不得有传染病或传染病。此后，应定期对其进行医学检查，至少每年一次，应保存记录。
13. 基础设施：组织应确定、提供和维护实现产品要求符合性所需的基础设施。
．建筑物、工作空间和相关公用设施
．工艺设备（硬体和软体）
．支持服务（例如运输或通讯）
．製造商应建立维护活动的书面要求，包括其频率，当此类活动或缺乏此类活动可能影响产品质量时。应保存此类维护的记录。
Specification for Quality Management System (QMS)
Manufacture of medical devices shall comply with the requirements, establish, record, implement and maintain quality management and maintain its effectiveness, and the documents shall include:
1. Written statement of quality policy and quality objectives.
2. Quality Manual.
．The scope of the quality management system, including details and justifications for any exclusions or inapplicability or both.
．A documented procedure established for the quality management system, or a reference to it.
．A description of the interaction between the processes of the quality management system. Contains specific information on facilities, personnel and other details.
3. Documenting procedures.
4. Documents required by the manufacturer to ensure the efficient planning, operation and control of its processes.
5. Records of procedures, events or special arrangements.
6. Documentation controls shall be controlled in accordance with the requirements given in Records Controls. Documents should be approved, signed and dated by appropriately authorized personnel. A documented procedure should be established to define the controls required
．Fully review and approve documents prior to publication
．Review and update documents and re-approve documents as necessary
．Ensure changes to documents and current revision status are identified
．Ensure relevant versions of applicable documents are available at the point of use
．Ensure documents remain legible and easily identifiable
．Make sure to identify files from outside and control their distribution
．Prevent accidental use of outdated files
7. Records Control: Records should be retained for at least one year after the expiration of the medical device’s validity period.
8. Management Responsibility: The manufacturer’s top management shall provide a commitment to the development and implementation of a quality management system and maintain its effectiveness through the following means.
．Communicate with staff the importance of meeting customer and statutory and regulatory requirements
．Develop a quality policy
．Make sure to establish quality goals
．Make an administrative review
．Ensure resource availability
9. Quality Policy: The manufacturer’s top management shall ensure the quality policy
．Fit for purpose of manufacturing facility
．Includes a commitment to comply with requirements and maintain the effectiveness of the quality management system
．Provides a framework for establishing and reviewing quality objectives
．Communicate within the manufacturer’s organization
．Review Continued Applicability
10. Quality Objectives: The manufacturer’s top management shall ensure that quality objectives are established at relevant functions and levels within the manufacturing organization, including those required to meet product requirements. Quality objectives should be measurable and consistent with the quality policy.
11. Resource provision: The manufacturing organization shall identify and provide the required resources
．Implement quality management and maintain its effectiveness
．Compliance with regulations and meeting customer requirements
12. Human resources: Personnel engaged in work that affects product quality should receive appropriate education, training, and skills. The number of personnel employed should be sufficient and proportional to the workload. All personnel should undergo a physical examination, including an eye examination, and be free from infectious diseases or communicable diseases before starting work. Thereafter, they should undergo regular medical examinations, at least once a year, and records should be kept.
13. Infrastructure: The organization shall identify, provide and maintain the infrastructure required to achieve compliance with product requirements.
．Buildings, Workspaces and Associated Utilities
．Process equipment (hardware and software)
．Support services (such as shipping or communications)
．Manufacturers shall establish written requirements for maintenance activities, including their frequency, when such activities, or lack thereof, may affect product quality. Records of such maintenance shall be kept.
【参考连结】
HLF-TW-75
HLF-TW-77
HLF-TW-80
外国子公司进口医疗器材后，如果委託印度的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports medical devices and entrusts a distributor in India to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
无须申请营业许可证。
当发生不良事件，主管机关有权力要求进口商立即启动召回，以防用户或患者的健康构成风险。
进口商有责任说明其撤回的原因、发送通知，并且需要提交定期安全性更新报告并建立警戒系统。
No business license is required.
When an adverse event occurs, the competent authority has the power to require the importer to initiate a recall immediately, in case the health of the user or patient poses a risk. Importers are responsible for explaining the reasons for their withdrawal, sending notices, and are required to submit regular security updates and establish a vigilance system.
【参考连结】
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
HLF-TW-85
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或
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